(72 days)
The device is intended for use in stabilizing and fixating bone grafts, bone filling material and/or barrier membranes used for guided bone/tissue regeneration in the oral cavity. Single patient use only.
The Jeil Bone Fixation System is comprised of bone screws, bone plates and instruments. The bone screws are composed of the titanium alloy (ASTM F136-98) and the bone plates are composed of the pure titanium (ASTM F67 Grade 1). The screws are offered in following range; diameter (1.4 ~ 2.0mm) and length (4.0 ~ 16.0mm). Also, the tip of screw has different 2 types; the self-tapping available type and the type that require the pre-drilling. (Surgeon's option) The bone plate is offered in 0.1mm and 0.2mm thickness and in length 37mm and 24mm. The applied titanium mesh over the cavity provides stable mechanical support while maintaining the sufficient flexibility for placement with decreasing tissue compliance related complication. The applied titanium screw for the on-lay bone above the alveolar bone provides stable mechanical rigidity and stability. This device system and each device are provided non-sterile. Therefore, this device must be sterilized prior to use. Steam sterilization is recommended. This device is provided with kit or Polyethylene package bag. The top of package bag is scaled with sealing strip. This system could be used with various instruments as follows. Screw Block, Screw driver body, Driver shaft, Pilot drill.
The provided text is a 510(k) summary for the Jeil Bone Fixation System. This type of regulatory submission in the US (FDA) primarily focuses on demonstrating substantial equivalence to predicate devices already on the market, rather than conducting new clinical trials to prove safety and effectiveness de novo. Therefore, the typical "study" that proves the device meets acceptance criteria in this context is a comparison to legally marketed predicate devices.
Based on the provided document, here's what can be extracted regarding acceptance criteria and the "study":
1. Table of Acceptance Criteria & Reported Device Performance
The acceptance criteria here are implicitly defined by the characteristics of the predicate devices. The "reported device performance" is the comparison made between the Jeil Bone Fixation System and those predicates. Since no specific quantitative acceptance criteria (e.g., "tensile strength greater than X") are provided, the table below reflects the qualitative "acceptance criteria" through substantial equivalence.
| Acceptance Criterion (Implicit) | Reported Device Performance (Jeil Bone Fixation System) |
|---|---|
| Material Composition | Titanium Alloy (ASTM F 136) & Pure Titanium (ASTM F 67 Gr 1) - Matches materials used in predicate devices Straumann GBR, Osteo-Mesh, Dual Top Anchor, Leforte System Screws, and Leforte System Plates. |
| Intended Use | Stabilizing and fixating bone grafts, bone filling material, and/or barrier membranes used for guided bone/tissue regeneration in the oral cavity. - Matches the intended use of the Straumann GBR System and is consistent with the general purpose of bone fixation in the oral cavity. |
| Single Use Only | Yes - Matches all predicate devices. |
| Sterility | Non-Sterile (Sterilize before use) - Matches all predicate devices for which this information is provided. |
| Design & Dimensions (Screws) | Diameter (1.4 ~ 2.0mm), Length (4.0 ~ 16.0mm), Self-tapping or pre-drilling types. - Stated to have "similar dimensions" to predicate devices. |
| Design & Dimensions (Plates) | Thickness (0.1mm, 0.2mm), Length (24mm, 37mm). - Stated to have "similar dimensions" to predicate devices. |
| Potential Adverse Effects | Identical to those of predicate devices (e.g., poor bone formation, osteomyelitis, migration, metal sensitivity, pain, increased fibrous tissue response, necrosis of bone, inadequate healing, infection, nerve damage). |
| Overall Design, Material, Intended Use, and Function | Substantially equivalent to the listed predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: This document does not describe a "test set" in the traditional sense of a clinical or performance study with a specific number of patients or samples. The "study" is a comparison against existing predicate devices and their known characteristics. Therefore, there is no discrete "sample size" for a test set.
- Data Provenance: The data provenance is based on the specifications and regulatory information of previously cleared predicate devices listed (Straumann GBR System, Osteo-Mesh TM-300, Dual Top Anchor System, Leforte System Screws, Leforte System Plates). This is inherently retrospective, as it examines information related to already marketed devices. The origin of the predicate device data is not specified in this document, but they are all legally marketed through the FDA, implying US market authorization.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Experts: Not applicable. This submission relies on substantial equivalence to predicate devices, not on expert adjudication of new clinical or image data. The "ground truth" is the established regulatory status and characteristics of the predicate devices.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There was no test set requiring adjudication in this type of submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No. This document describes a 510(k) submission based on substantial equivalence, not a clinical trial or MRMC study evaluating human reader performance with or without AI assistance. The device is a bone fixation system, not an AI or imaging diagnostic tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance Study: No. This device is an implantable medical device (bone fixation system), not an algorithm or software. Its performance is evaluated based on its physical properties, materials, and intended use in comparison to similar existing devices, within the context of a surgical procedure involving human intervention.
7. The Type of Ground Truth Used
- Ground Truth: The "ground truth" for this 510(k) submission is the established safety and effectiveness profile and technical characteristics of the legally marketed predicate devices. The new device is deemed acceptable if it demonstrates substantial equivalence to these established devices in terms of materials, intended use, design, and other relevant properties.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. There is no concept of a "training set" in this 510(k) submission. It is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
- Training Set Ground Truth Establishment: Not applicable. As there is no training set, there is no ground truth for it to be established.
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.